MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS CVD FEM ST W/O BODY 11X127; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853811
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported that patient's right knee was revised due to a broken stem (break was at taper junction plus 2 cm).No trauma was reported but the patient is a very active farmer.Patient was revised by resecting the femur further up and placing a gmrs 160mm stem.
Event or Problem Description
It was reported that patient's right knee was revised due to a broken stem (break was at taper junction plus 2 cm).No trauma was reported but the patient is a very active farmer.Patient was revised by resecting the femur further up and placing a gmrs 160mm stem.
Additional Manufacturer Narrative
An event regarding crack fracture involving a mrs stem was reported.Crack fracture was confirmed as a result of a material analysis.Osteolysis was confirmed on review of the provided medical records by a clinical physician.Although osteolysis is confirmed, it is noted that this condition was not addressed during the previous revision event which was reported separately and therefore, the stem is being reported for fracture and no other reports are being generated for this specific event.Method & results: device evaluation and results: a visual inspection was performed by a material analysis engineer which noted; the stem had fractured approximately 2.5 inches from the proximal tip of the stem.The distal end of the stem was not returned.Damage was observed on the stem consistent with the implantation and explantation process.Post-fracture abrasion was observed on the fracture surface, obscuring regions of the fracture surface.A material analysis concluded; the device fractured in fatigue with the final fracture occurring in overload.Medical records received and evaluation: a review of the medical records by a clinical consultant noted; osteolysis as caused by tibial device loosening requiring revision in 2017 with tibial device only exchange also adversely affected distal femoral fixation with osteolysis and loss of bone support around the most distal femoral stem section.The femoral problem was not addressed during this revision surgery and thus the femoral overload condition could persist and contribute to a fatigue fracture of the distal femoral stem section 1-year later exactly at the level of peak overload requiring another revision of now the femoral gmrs side.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: a medical review concluded osteolysis and an overload condition could have contributed to a fatigue fracture of the distal femoral stem.The exact cause of the event could not be determined.If additional information become available, this investigation will be reopened.

• Brand Name: MRS CVD FEM ST W/O BODY 11X127
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7808995
• Report Number: 0002249697-2018-02661
• Device Sequence Number: 19216141
• Product Code: KRO
• UDI-Device Identifier: 07613327049787
• UDI-Public: 07613327049787
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 64853811
• Device Lot Number: TEC661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR